ATTUNE 2545-00-131Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10603295130956), received between Feb 7, 2018 and Sep 2, 2026 — classified as 1 injury, 97 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (69 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Device-Device Incompatibility; Scratched Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50555485 ↗
• MalfunctionJun 5, 2026Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE ATTUNE CEMENTED DRILL AND DRILL TOWER BEGAN TO BIND DURING TIBIAL PREP. THE INSTRUMENTS WERE IMMEDIATELY REMOVED AND A NEW TRAY WAS OPENED. INSPECTION REVEALED SCORING ON BOTH INSTRUMENTS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410295 ↗
• MalfunctionApr 3, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DRILL TOWER AND TIBIAL DRILL DIDN¿T MEET WELL AND CREATED METAL FILINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776210 ↗
• MalfunctionApr 3, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DRILL TOWER AND TIBIAL DRILL DIDN¿T MEET WELL AND CREATED METAL FILINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776169 ↗
• MalfunctionApr 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL DRILL WOULD STICK ON TOWER. IT WAS TOO TIGHT AND BONDED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753182 ↗
• MalfunctionMar 17, 2026No Apparent Adverse Event

  INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617130 ↗
• MalfunctionJan 15, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY, THE TIBIAL DRILL AND THE DRILL TOWER OF ATTUNEM2 WAS STRUCK TOGETHER AND CANNOT FUNCTION DURING SURGERY. NO ADVERSE EFFECT TO THE PATIENT AND NO DELAY TO THE SURGERY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/OUTCOME/CONSEQUENCES. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24089252 ↗
• MalfunctionJan 14, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE TOWER AND DRILL SURFACES NOT ALIGNED PROPERLY. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071546 ↗
• MalfunctionJan 14, 2026Device-Device Incompatibility

  2545-00-131 ATTUNE TIBIAL DRILL TOWER. 2545-00-165 ATTUNE LINE TO LINE CEMENTED TIBIAL DRILL WERE BOTH FOUND TO BE NON WORKING DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071511 ↗
• MalfunctionDec 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT BOSS DRILL WOULD NOT PASS THROUGH DRILL TOWER, REQUESTED DRILL TOWER BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849677 ↗
• MalfunctionDec 19, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE TIBIAL DRILL WOULD NOT ADVANCE THROUGH THE TIBIAL DRILL TOWER, AS THERE WAS SCORING ON THE INSIDE OF THE TOWER. IT WAS REPORTED THAT THE INSTRUMENT WAS PUT TO THE SIDE AND A NEW INSTRUMENT SET WAS OPENED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847964 ↗
• MalfunctionNov 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. COULD YOU PLEASE CONFIRM IF THE DEVICE TIBIAL DRILL, PN:(B)(4) WAS USED FOR THE FIRST TIME, AT THE HOSPITAL, WHEN THE EVENT OCCURRED? - ONE OF THE TWO INSTRUMENTS WAS NOT FITTING THE OTHER ONE FROM THE BEGINNING. B. PLEASE CLARIFY IF THE DEVICE HAD ALREADY BEEN DAMAGED ON THE SHAFT (FROM USE) OR IF IT WAS LIKE NEW OUT FROM THE INSTRUMENT SET? - IT TURNED OUT LIKE THIS AFTER BEING USED WITH THE OTHER ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512814 ↗
• MalfunctionNov 5, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE DRILL TOWER WOULD NOT LET THE DRILL THROUGH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475304 ↗
• MalfunctionOct 30, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON WENT TO PREP THE TIBIA AND THE TIBIAL DRILL BEGAN BINDING. IMMEDIATELY A NEW TRAY WAS OPENED TO RESOLVE THE ISSUE. A MORE IN DEPTH LOOK POST OP FOUND THAT THE DRILL APPEARED TO BE WARPED AND THERE WAS SCORING ON THE INSIDE OF THE PREP TOWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423396 ↗
• MalfunctionOct 23, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE DRILL AND TOWER HAVE BEEN WARPED. THE DRILL NO LONGER FIT THROUGH TOWER. BOTH INSTRUMENTS WERE DISCARDED BY THE SURGICAL TECH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369493 ↗
• MalfunctionOct 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PINS OF THE INSTRUMENT ARE DEFORMED/BENT. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES. THE ISSUE WAS IDENTIFIED IN CENTRAL STERILE SUPPLY DEPARTMENT (CSSD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349772 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIA DRILL WAS NOT GLIDING THROUGH SMOOTHLY. IT WAS BINDING UP. EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289981 ↗
• MalfunctionAug 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL TOWER HAD A DEFECT THAT PREVENTS THE DRILL AND KEEL PUNCH FROM GOING THROUGH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714825 ↗
• MalfunctionJul 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIA DRILL TOWERS AND DRILL WERE JAMMING AND CATCHING, CAUSING THEM TO NOT BE ABLE TO REAM DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529980 ↗
• MalfunctionJul 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIA DRILL TOWERS AND DRILL WERE JAMMING AND CATCHING; CAUSING THEM TO NOT BE ABLE TO REAM DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529964 ↗
• MalfunctionMay 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL DRILL WOULD NOT SMOOTHLY TRANSFER THROUGH THE DRILL TOWER DUE TO WEAR ON BOTH THE TIBIAL DRILL AND TOWER. BACK UP TRAYS WERE OPENED AND COMPLETED THE CASE. THE PATIENT WAS NOT HARMED. THE OUTCOME OF THE SURGERY WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107393 ↗
• MalfunctionMay 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL DRILL WOULD NOT SMOOTHLY TRANSFER THROUGH THE DRILL TOWER DUE TO WEAR ON BOTH THE TIBIAL DRILL AND TOWER. BACK UP TRAYS WERE OPENED AND COMPLETED THE CASE. THE PATIENT WAS NOT HARMED. THE OUTCOME OF THE SURGERY WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107392 ↗
• MalfunctionMay 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL DRILL WOULD NOT SMOOTHLY TRANSFER THROUGH THE DRILL TOWER DUE TO WEAR ON BOTH THE TIBIAL DRILL AND TOWER. BACK UP TRAYS WERE OPENED AND THE CASE WAS COMPLETED. THE PATIENT WAS NOT HARMED. THE OUTCOME OF THE SURGERY WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105155 ↗
• MalfunctionMay 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL DRILL WOULD NOT SMOOTHLY TRANSFER THROUGH THE DRILL TOWER DUE TO WEAR ON BOTH THE TIBIAL DRILL AND TOWER. BACK UP TRAYS WERE OPENED AND THE CASE WAS COMPLETED. THE PATIENT WAS NOT HARMED. THE OUTCOME OF THE SURGERY WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105138 ↗
• MalfunctionMay 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DRILL TOWER WILL NOT FIT THE TIBIAL DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996539 ↗